Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients
2 other identifiers
interventional
200
1 country
1
Brief Summary
The objective is to assess the effect of simvastatin on immunology, inflammatory, and coagulation responses, and mortality in elderly with pneumonia based. The primary outcome is mortality event. The hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 6, 2012
August 1, 2012
1.1 years
July 24, 2012
August 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
30 days
Secondary Outcomes (4)
Change from baseline in TNF-α (Tumor Necrosis Factor alpha) concentration
Baseline and 7 days
Change from baseline in Interferon-gamma (INF-ϒ) concentration
Baseline and 7 days
Change from baseline in Plasminogen Activator Inhibitor-1 (PAI-1) concentration
Baseline and 7 days
Change from baseline in C-Reactive Protein (CRP) concentration
Baseline and 7 days
Study Arms (2)
Simvastatin
EXPERIMENTALTablet 20 mg once daily for 30 days
Placebo
PLACEBO COMPARATORPlacebo tablet once daily for 30 days
Interventions
Tablet 20 mg once daily for 30 days
Eligibility Criteria
You may qualify if:
- Elderly patients with pneumonia
You may not qualify if:
- Severe septic condition
- Hepatic Cirrhosis
- Acute coronary disease
- Total cholesterol which is too high or too low
- In anticoagulant therapy
- In steroid therapy or other immunosuppressant therapy
- Have refused to join the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10340, Indonesia
Related Publications (2)
Dublin S, Jackson ML, Nelson JC, Weiss NS, Larson EB, Jackson LA. Statin use and risk of community acquired pneumonia in older people: population based case-control study. BMJ. 2009 Jun 16;338:b2137. doi: 10.1136/bmj.b2137.
PMID: 19531550BACKGROUNDThomsen RW, Riis A, Kornum JB, Christensen S, Johnsen SP, Sorensen HT. Preadmission use of statins and outcomes after hospitalization with pneumonia: population-based cohort study of 29,900 patients. Arch Intern Med. 2008 Oct 27;168(19):2081-7. doi: 10.1001/archinte.168.19.2081.
PMID: 18955636BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuntjoro Harimurti, MD, MSc
Department of Internal Medicine, Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., M.Sc.
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 27, 2012
Study Start
July 1, 2012
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
August 6, 2012
Record last verified: 2012-08